Temperature controlled pharmaceutical storage device with alarm detection and indication means

Abstract

A temperature-controlled pharmaceutical device includes a substantially enclosed and thermally insulated structure having at least one port which allows access to an enclosed storage area which has a storage temperature. A thermopile heat exchange unit is provided for heating and cooling the storage area in response to signals provided by temperature sensors and a window detector. The storage area is maintained at a temperature between upper and lower predetermined limits. When these limits are exceeded for a predetermined length of time, a visual display is actuated to warn that the substances should be discarded immediately. After signaling an alarm, the indicator is reset by way of a lock switch. The lock switch discourages unauthorized resetting. An energy saving switching mechanism is provided for overriding the heat exchanger circuitry when the port to the enclosed area is open, preventing unnecessary discharge of the battery pack. A drainage plate is provided in the lower region of the storage area to separate condensate and moisture from the articles stored in the storage device. The electronics, battery pack, and heat exchange unit are modular and designed to be quickly and easily decoupled from the storage device.

We claim: 
     
       1. A temperature-controlled pharmaceutical storage apparatus for containing temperature sensitive pharmaceutical substances which must be maintained within a range of temperatures to avoid diminishment of potency or shelf life, comprising: a) a substantially enclosed and thermally insulated structure, having at least one port which opens to allow access to an enclosed storage area having a storage temperature;   b) means for selectively heating and cooling said storage area of said substantially enclosed and thermally insulated structure;   c) means for detecting elevation of said storage temperature above a selected maximum storage temperature, and for actuating said means for selectively heating and cooling to lower said storage temperature below said selected maximum storage temperature;   d) means for detecting lowering of said temperature below a selected minimum temperature, and actuating said means for selectively heating and cooling to raise said storage temperature above said selected minimum temperature;   e) means for detecting and indicating a first alarm condition when said storage temperature rises above said maximum storage temperature to a first selected critical temperature which would impair the potency of temperature sensitive pharmaceutical substances stored within said storage area, said means for detecting and indicating a first alarm condition further comprising means for maintaining an alarm indication regardless of any subsequent changes in said storage temperature;   f) means for detecting and indicating a second alarm condition when said storage temperature falls below a minimum storage temperature to a second selected critical temperature which would impair the potency of temperature sensitive pharmaceutical substances stored within said storage area, said means for detecting and indicating a second alarm condition further comprising means for maintaining an alarm indication regardless of any subsequent changes in said storage temperature;   g) wherein said maximum storage temperature constitutes an upper temperature level above which potency of said temperature sensitive pharmaceutical substances may be impaired, and wherein said minimum storage temperature constitutes a lower temperature level below which potency of said temperature sensitive pharmaceutical substances may be impaired.   
     
     
       2. A temperature-controlled pharmaceutical storage apparatus according to claim 1, further comprising an override means for disabling said means for cooling and said means for heating when said at least one port is open. 
     
     
       3. A temperature-controlled pharmaceutical storage apparatus according to claim 1, further comprising at least one rechargeable battery for powering said means for cooling and said means for heating. 
     
     
       4. A temperature-controlled pharmaceutical storage apparatus according to claim 1, wherein said selected maximum storage temperature is approximately 86 degrees Fahrenheit, and wherein said minimum storage temperature is approximately 59 degrees Fahrenheit to maintain said storage temperature within a range of pharmaceuticals which do not adversely affect the potency of most temperature sensitive temperature substances. 
     
     
       5. A temperature-controlled pharmaceutical storage apparatus according to claim 1, wherein said selected maximum storage temperature, and said selected minimum storage temperature are preset at fixed temperature values. 
     
     
       6. A temperature-controlled pharmaceutical storage apparatus for controlling temperature sensitive pharmaceutical substances which must be maintained within a range of temperatures to avoid diminishment of potency or shelf life, comprising: a) a substantially enclosed and thermally insulated structure, having at least one port which opens to allow access to an enclosed storage area having a storage temperature;   b) a thermopile heat exchange means for cooling said enclosed storage area when operated in a cooling mode, and for heating said enclosed area when operated in a heating mode;   c) a temperature sensor for continually monitoring said storage temperature;   d) detector means for detecting when said storage temperature is outside of a predetermined range of temperatures, said detector means being connected to said temperature sensor and to said thermopile heat exchanger means, said detector means operating said thermopile heat exchanger means when said storage temperature is outside of said predetermined range to bring said storage temperature within said predetermined range;   e) at least one battery for powering said thermocouple heat exchange means;   f) override means for disabling said thermopile heat exchange means when said at least one port is open, for preserving said at least one battery.   
     
     
       7. A temperature-controlled pharmaceutical storage apparatus for controlling temperature sensitive pharmaceutical substances according to claim 6, wherein said thermopile heat exchange means comprises a modular unit which releasably couples to said substantially enclosed and thermally insulated structure. 
     
     
       8. A temperature-controlled pharmaceutical storage apparatus for controlling temperature sensitive pharmaceutical substances according to claim 6, further comprising: a) a modular battery pack including said at least one battery, which releasably couples to said substantially enclosed and thermally insulated structure.   
     
     
       9. A temperature-controlled pharmaceutical storage apparatus for controlling temperature sensitive pharmaceutical substances according to claim 6, further comprising: a) means for indicating that said at least one battery requires recharging;   b) means for recharging said at least one battery.   
     
     
       10. A temperature-controlled pharmaceutical storage apparatus for controlling temperature sensitive pharmaceutical substances which must be maintained within a range of temperatures to avoid diminishment of potency or shelf life, comprising: a) a substantially enclosed and thermally insulated structure, including: i) a substantially rectangular base, having upper and lower regions;   ii) a divider plate disposed in said substantially rectangular base, separating said upper region from said lower region, and having a plurality of drainage ports;   iii) a desiccant means for absorbing moisture, disposed in said lower region;   iv) a cover for enclosing said substantially rectangular base;   v) wherein said upper region serves as a storage area having a storage temperature, and said lower region services as a drainage bin for condensate;     b) a thermopile heat exchange means for cooling said enclosed storage area when operated in a cooling mode, and for heating said enclosed area when operated in a heating mode;   c) a temperature sensor for continually monitoring said storage temperature;   d) detector means for detecting when said storage temperature is outside of a predetermined range of temperatures, said detector means being connected to said temperature sensor and to said thermopile heat exchanger means, said detector means operating said thermopile heat exchanger means when said storage temperature is outside of said predetermined range to bring said storage temperature within said predetermined range;   e) at least one battery for powering said thermopile heat exchange means;   f) override means for disabling said thermopile heat exchange means when said at least one port is open, for preserving said at least one battery.   
     
     
       11. A device for storing pharmaceuticals within a predetermined temperature range, comprising: a) a container having top, bottom and side walls that form an interior compartment, said walls having thermal insulation therein, said top wall being capable of being opened so as to allow access into said interior compartment;   b) temperature sensor means for sensing the temperature of said interior compartment, said temperature sensor means being located within said interior compartment;   c) window detector means for detecting temperatures that are cooler than 59 degrees Fahrenheit and warmer than 86 degrees Fahrenheit, said window detector means having an input that is connected to said temperature sensor means;   d) thermopile means for heating and cooling said interior compartment, said thermopile means being located in said container and being thermally coupled to said interior compartment and to the exterior of said container;   e) switch means for selectively operating said thermopile means in a heating mode wherein said interior compartment is heated or in a cooling mode wherein said interior compartment is cooled, said switch means being coupled to an output of said window detector means and to said thermopile means, wherein when said window detector means and said temperature sensor means detect the temperature of said interior compartment as being below 59 degrees Fahrenheit, then said switch means operates said thermopile means to heat said interior compartment and when said window detector means and said temperature sensor means detect the temperature of said interior compartment as being above 86 degrees Fahrenheit, then said switch means operates said thermopile means to cool said interior compartment.   
     
     
       12. The device of claim 11, further comprising alarm indicator means, said alarm indicator means being coupled to a second output of said window detector means, said alarm indicator means being programmed with a predetermined time delay, wherein when said window detector means detects a temperature outside of the 59-86 degree Fahrenheit range, for said predetermined time delay, said alarm indicator means provides and maintains an indication of the temperature excess. 
     
     
       13. A device for storing pharmaceuticals within a predetermined temperature range, comprising: a) a container having top, bottom and side walls that form an interior compartment, said walls having thermal insulation therein, said top wall being capable of being opened so as to allow access into said interior compartment;   b) temperature sensor means for sensing the temperature of said interior compartment, said temperature sensor means being located within said interior compartment;   c) window detector means for detecting temperatures that are cooler than a predetermined minimum temperature and warmer than a predetermined maximum temperature, said window detector means having an input that is connected to said temperature sensor means;   d) thermopile means for heating and cooling said interior compartment, said thermopile means being located in said container and being thermally coupled to said interior compartment and to the exterior of said container;   e) switch means for selectively operating said thermopile means in a heating mode wherein said interior compartment is heated or in a cooling mode wherein said interior compartment is cooled, said switch means being coupled to an output of said window detector means and to said thermopile means, wherein when said window detector means and said temperature sensor means detects the temperature of said interior compartment as being below said predetermined minimum temperature, then said switch means operates said temperature means to heat said interior compartment and when said window detector means and said temperature sensor means detect the temperature of said interior compartment as being above said predetermined maximum temperature, then said switch means operates said thermopile means to cool said interior compartment;   f) alarm indicator means being coupled to a second output of said window detector means, said alarm indicator means being programmed with a predetermined time delay, wherein when said window detector means detects a temperature outside of the predetermined minimum temperature to predetermined maximum temperature range for said predetermined time delay, said alarm indicator means provides and maintains an indication of the temperature excess.   
     
     
       14. The device of claim 13 wherein: a) said alarm indictor means has a reset input wherein when said reset input is triggered, said alarm indicator means changes from an alarm mode to a non-alarm mode, said alarm mode providing said indication of the temperature excess;   b) said device further comprising security means for restricting unauthorized access to said reset input, said reset input being coupled to said security means.   
     
     
       15. The device of claim 13 further comprising trays for holding said pharmaceuticals, said trays being padded so as to reduce breakage of pharmaceuticals containers located in said trays. 
     
     
       16. The device of claim 13 further comprising a first battery for powering said thermopile means and said alarm indicator means and a backup battery for powering said alarm indicator means in the event that said first battery fails. 
     
     
       17. The device of claim 13 further comprising cutoff switch means for disabling said thermopile means when said top wall is opened, said cutoff switch means being located in said container adjacent to said top wall so as to be actuated by the opening of said top wall. 
     
     
       18. The device of claim 13 wherein said interior compartment has a divider plate that separates said interior compartment into upper and lower chambers, said upper chamber being adapted to receive said pharmaceuticals and said lower chamber receiving a desiccant material, said divider plate being perforated so as to allow moisture to pass therethrough. 
     
     
       19. The device of claim 13 wherein said thermopile means and said window detector means are contained in at least one module, said module being separable from said container so as to allow the replacement of said module. 
     
     
       20. The device of claim 13, further comprising: a) trays for holding said pharmaceuticals, said trays being padded so as to reduce breakage of pharmaceuticals containers located in said trays;   b) a first battery for powering said thermopile means and said alarm indicator means and a backup battery for powering said alarm indicator means in the event that said first battery fails;   c) said alarm indictor means has a reset input wherein when said reset input is triggered, said alarm indicator means changes from an alarm mode to a non-alarm mode, said alarm mode providing said indication of the temperature excess, said device further comprising security means for restricting unauthorized access to said reset input, said reset input being coupled to said security means.   
     
     
       21. The device of claim 20, further comprising: a) cutoff switch means for disabling said thermopile means when said top wall is opened, said cutoff switch means being located in said container adjacent to said top wall so as to be actuated by the opening of said top wall;   b) said interior compartment has a divider plate that separates said interior compartment into upper and lower chambers, said upper chamber being adapted to receive said pharmaceuticals and said lower chamber receiving a desiccant material, said divider plate being perforated so as to allow moisture to pass therethrough;   c) said thermopile means and said window detector means are contained in at least one module, said module being separable from said container so as to allow the replacement of said module.